MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513381
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).This event was reported by the distributor.The reported healthcare facility is: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was to be used for a gastrointestinal biopsy procedure performed on (b)(6) 2021.During preparation, a hair-like foreign object was found inside the sterile area of the packaging.No damage was noted in the packaging and it was sealed.Another radial jaw 4 biopsy forceps was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block e1: this event was reported by the distributor.The reported healthcare facility is: (b)(6).Block h2: additional information: b5 event description, e1 initial reporter address.Block h6: medical device problem code a1802 captures the reportable event of packaging foreign matter.Block h10: the returned radial jaw 4 biopsy forceps pouch was analyzed, and a visual inspection noted that the sealed areas of the pouch were intact.No hair was found on the pouch.The reported event was not confirmed.Based on all available information, device analysis found no issues with the pouch during visual test.Therefore, the most probable cause code is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 standard capacity biopsy forceps was to be used for a gastrointestinal biopsy procedure performed on (b)(6) 2021.During preparation, a hair-like foreign object was found inside the sterile area of the packaging.No damage was noted in the packaging and it was sealed.Another radial jaw 4 biopsy forceps was used to complete the procedure.There were no patient complications as a result of this event.A photo was provided confirming the reported event.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12378456
• Report Number: 3005099803-2021-04406
• Device Sequence Number: 4115629
• Product Code: FCL
• UDI-Device Identifier: 08714729777953
• UDI-Public: 08714729777953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: M00513381
• Device Catalogue Number: 1338
• Device Lot Number: 0027109659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1